A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
NCT ID: NCT02263417
Last Updated: 2023-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2015-07-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Deep Brain Stimulation
Stimulation is on
Deep Brain Stimulation (DBS) of Gpi
Deep Brain Stimulation (DBS) of STN
Placebo
Stimulation is off
Deep Brain Stimulation (DBS) of Gpi
Deep Brain Stimulation (DBS) of STN
Interventions
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Deep Brain Stimulation (DBS) of Gpi
Deep Brain Stimulation (DBS) of STN
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with cervical dystonia by a movement disorders neurologist.
3. Has cervical dystonia alone, not generalized or multifocal.
4. Has had adequate trials of medical therapy.
Exclusion Criteria
2. Abnormalities on pre-operative magnetic resonance imaging (MRI).
3. Medical conditions precluding general anaesthetic or surgery.
4. Unstable psychiatric disease.
5. Previous brain lesions to treat cervical dystonia.
6. Attended some other trials within three month.
18 Years
75 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Li Luming, PhD
Role: STUDY_CHAIR
Tsinghua University
Locations
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Peking union medical college hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PINS-005
Identifier Type: -
Identifier Source: org_study_id
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